Percutaneous access pathway system and method

ABSTRACT

An improved method and device are provided for forming and/or maintaining a percutaneous access pathway. The device generally comprises at least one of three type of components: access pathway, insertion device, and attachment device. In one embodiment, the device is used to form and/or maintain a percutaneous access pathway into the pleural cavity (i.e. tube thoracostomy). The provided assembly substantially reduces the possibility of iatrogenic infection while accessing and/or re-accessing a body space.

RELATED APPLICATIONS

The present application claims the benefit of U.S. ProvisionalApplication No. 61/920,963 filed Dec. 26, 2013, which is incorporatedherein in its entirety by reference. U.S. patent application Ser. No.13/961,422, filed Aug. 7, 2013 and entitled Method and Device forSimultaneously Documenting and Treating Tension Pneumothorax and/orHemothorax, having the same inventor as the present application, is alsohereby incorporated by reference herein in its entirety.

FIELD OF THE INVENTION

The present disclosure relates generally to the field of medicaldevices, and more particularly, to devices and methods for formingand/or maintaining a percutaneous access pathway. In one application,the present invention relates to methods and devices for draining airand/or fluids from the body of a patient.

BACKGROUND OF THE INVENTION

A wide variety of diagnostic and/or therapeutic procedures involves theintroduction of a device through a natural or artificially createdpercutaneous access pathway in a body of a patient. One of the generalobjectives of access systems developed for this purpose is to minimizethe chances of iatrogenic injury to the patient, including laceration ofvital structures or the introduction of infectious organisms from theskin or external environment into the body.

Tube thoracostomy (i.e. the percutaneous placement of a chest tube intothe pleural space) is an example of one type of interventional procedurethat requires an artificially created pathway. There are severalpossible reasons for needing to place a chest tube into the pleuralspace (the space between the visceral pleura covering a lung and theparietal pleura covering the inside of the chest wall). These reasonsmay be medical or traumatic in nature, and include the drainage of awide range of fluids, such as blood (hemothorax), air (pneumothorax),pleural effusion, serous fluid (hydrothorax), chyle (chylothorax), andpus (pyothorax).

There are several methods currently employed to place a chest tube intothe body. The chest tube may be inserted by pushing it through the chestwall over a sharp trocar, although this risks lacerating the underlyingorgans with the sharp trocar. Tube thoracostomy is typically performedvia an open surgical approach, which involves cutting the skin with ascalpel and then dilating the underlying tissues with a forceps or otherblunt instrument before inserting one or more chest tubes. Thismultistep process still risks lacerating the neurovascular bundleunderneath the rib, but has less chance of damaging deeper organs.Alternatively, the Seldinger technique is another option, wherein aneedle is initially advanced, then a guide wire inserted through theneedle, the needle is removed, dilator(s) are positioned over the wire,and finally the chest tube is placed. This has less chance of damagingvital structures, but is lengthy in practice.

All current methods share some drawbacks including the aforementionedrisks of damaging underlying structures, as well as the need to performtube thoracostomy under a relatively large sterile field due to chesttube length. This makes it difficult to maintain sterility outside ofthe operating room, for example in the emergency department, in theout-of-hospital arena, or on the battlefield. Additionally, the portionof the chest tube outside the body immediately becomes unsterile afterfinishing the procedure. Thus, the chest tube should not be movedfurther into the patient after initial placement if it was inserted tooshallowly or becomes dislodged. Similarly, if the tube becomesirreversibly clogged, a sterile field needs to be reestablished in orderto replace the chest tube.

Roberts and Hedges' Clinical Procedures in Emergency Medicine, 6th ed.“Chapter 10—Tube Thoracostomy.” 2013, Saunders, contains additionalinformation regarding tube thoracostomy.

The literature discloses various additional known methods and devicesfor forming and/or maintaining a percutaneous access pathway, many ofwhich are improvements specifically regarding tube thoracostomy.

For example, U.S. Publication No. 2007/0038180 to Sinha et al. describesa chest tube insertion gun that pushes the chest tube through the chestwall using a sharp trocar. This is a mechanical version of the trocarmethod and it still has the noted drawback of potential injury tounderlying organs from the sharp trocar.

U.S. Publication No. 2006/0025723 to Ballarini and U.S. Pat. No.5,897,531 to Amirana describe devices for securing a chest tube to theexternal skin of a patient. Although this helps hold the tube afterplacement, it does not establish a percutaneous entrance. U.S.Publication No. 2008/0103451 to Schaefer and U.S. Pat. No. 4,221,215 toMandelbaum, U.S. Pat. No. 5,215,531 to Maxson et al., and U.S. Pat. No.5,263,939 to Wortrich are other similar examples of external anchoringmechanisms for percutaneous tubes. Similarly, U.S. Pat. No. 6,638,253 toBreznock describes a chest tube with an internal check valve, distalholes that open using a central rod, and a balloon holding the deviceinside the patient. Although this anchors the tube to the patient fromthe inside, it does not reduce the chance of iatrogenic injury orinfection.

Several prior works describe the placement of percutaneous accesspathway ports into the body, which allow entrance into inner cavities.Chinese Patent No. 1,756,513B and U.S. Pat. Nos. 7,811,293 and 7,842,058to Simpson et al. describe a cutting gun that inserts a port for chesttube placement. After port placement, a chest tube can be inserted intothe body thought the port opening. However, this still has thelimitations of possible iatrogenic laceration of underlying vitalstructures with the sharp moving blades, as well as difficultymaintaining a sterile field outside of the operating room.

Other transcutaneous ports include mechanisms for reduced infection riskand pain. For example, U.S. Pat. No. 3,777,757 to Gray et al. describesan inflatable chest tube port to increase patient comfort. Othersinclude U.S. Pat. No. 3,789,852 to Kim et al.; U.S. Pat. No. 5,545,179to Williamson, I V; and U.S. Pat. No. 4,767,411 to Edmunds and U.S.Publication No. 2004/0078026 to Wagner. Further, U.S. Pat. Nos.8,518,053; 8,430,094; and 7,824,366 and U.S. Publication Nos.2009/0205646; 2010/0170507; and 2009/0205651 to Tanaka, et al., as wellas U.S. Pat. No. 8,062,315 to Aster et al. all describe transcutaneousports placed to specifically establish a pneumostoma (a transcutaneoushole terminating inside the lung tissue itself, as opposed to thepleural space around the lung in tube thoracostomy). However, these donot significantly mitigate the limitations of transcutaneous portinsertion.

Prior works describe some improvements in transcutaneous access via theuse of expanding catheters or other dilatational devices. For example,U.S. Publication No. 2013/0131645 to Tekulve describes a chest tube thathas an internal diameter that inflates and deflates to remove cloggedblood. However, this is only an internal mechanism and does notsignificantly change the external diameter of the chest tube. U.S.Publication No. 2007/0021768 to Nance et al. describes an expandabletube for nephrostomy procedures, however it has no improved sterilitymechanism and does not have other benefits related to tube thoracostomy.

Other examples include U.S. Publication No. 2009/0318898 to Dein thatdescribes a chest tube capable of deflation to provide easier removalfrom the body and U.S. Pat. No. 8,128,648 to Hassidov et al. thatdescribes a gun with an expandable cutting trocar for use in placing achest tube. However, neither provides an improved port fortranscutaneous access into the body or an improved method formaintaining sterility during placement.

Finally, U.S. Publication No. 2011/0152874 to Lyons describes a balloondilatational chest tube apparatus and method that is an improvement overthe traditional Seldinger technique, in that it partially reduces thenumber of steps needed. A balloon distal to a chest tube inflates andthen deflates so that the chest tube can be advanced into the dilatedspace (and over the deflated balloon). While an improvement, this workstill is limited in that the chest tube must be pushed through chestwall tissue over the deflated balloon; there is no reusable port foreasier changing of clogged or misplaced chest tube(s), and it does notsignificantly improve the sterility of the tube thoracostomy procedure.

The prior art contains several works relevant to infection reduction andthe improvement of sterility during the establishment of a percutaneousaccess pathway. There are several examples of flexible sheaths tomaintain sterility around percutaneous catheters. For example, U.S. Pat.No. 5,807,341 to Heim; U.S. Pat. No. 6,605,063 to Bousquet; U.S. Pat.No. 5,662,616 to Bousquet; and U.S. Pat. No. 4,392,853 to Muto and U.S.Publication No. 2012/0191044 to Koike describe such sheaths aroundvenous catheters. Similarly, U.S. Pat. No. 5,242,398 to Knoll et al.;U.S. Pat. No. 7,789,873 B2 to Kubalak et al.; and U.S. Pat. No.3,894,540 to Bonner, Jr. describe such sheaths around urinary catheters.U.S. Pat. No. 4,767,409 to Brooks and U.S. Pat. No. 5,215,522 to Page etal. describe such sheaths around central venous pressure catheter andendotracheal tube suction devices, respectively. However, such flexiblesheaths have not been described previously for chest tubes and are notoptimally designed to maintain sterility in connection with a port.

U.S. Pat. Nos. 5,336,193 and 5,429,608 to Rom et al. and U.S.Publication No. 2008/0125750 to Gaissert describe bags to minimize theprovider's exposure to bodily fluids during chest tube removal. However,they do not introduce reusable percutaneous access pathway ports orreduce the chance of infection to the patient during placement.

Another example is U.S. Pat. No. 7,244,245 to Purow that describes arigid sheath device to maintain chest tube adhesion to the chest walland prevent pneumothorax. However, this follows standard chest tubeinsertion techniques and provides minimal reduction of infection.

Finally, U.S. Pat. Nos. 6,905,484 and 7,135,010 to Buckman et al.describe a military chest tube over a trocar in a sterile package.However, although the sterile packaging provides some benefit inminimizing infection risk, the works do not describe a mechanism formaintaining sterility within the system after puncturing the packagingwith the chest tube, as the tube then becomes exposed to the outerenvironment. Additionally, there is no easily reusable percutaneousaccess pathway established.

Regardless of use, the transcutaneous access devices and methods of theart have not before provided for accessing and/or re-accessing a body tooptimally minimize iatrogenic injury, while maintaining sterility withina closed system. As such, there is a need for a device and method to doso.

Each of the patents and published patent applications mentioned aboveare hereby incorporated by reference.

SUMMARY OF THE INVENTION

The present invention overcomes and substantially alleviates thedeficiencies in the prior art by providing improved devices and methodsfor forming and/or maintaining a percutaneous access pathway.

In one embodiment, the device is used to form and/or maintain apercutaneous access pathway into the pleural cavity (i.e. tubethoracostomy). This channel can then be used to introduce part of anattachment device (e.g. chest tube(s) of different sizes, pigtailcatheter, endoscope, video-assisted thoracoscopic surgery device, and/orother surgical instruments), if so desired.

Under various embodiments, the initial percutaneous access pathway isformed via different methods and devices, which include theaforementioned techniques noted as background of the present inventionthat have been incorporated by reference. These include but are notlimited to an open surgical approach; a trocar with or without anoverlying catheter; a hollow needle with or without an overlyingcatheter; the standard Seldinger technique; a modified Seldingertechnique (e.g. as described in U.S. Publication No. 2011/0152874 toLyons); an expandable catheter; a Veress-type needle; a twisting screwor drill bit or needle; combinations of these methods and/or devices;and other methods and devices well known in the art.

In some embodiments, the initial percutaneous access pathway is formedsimilarly to the device and/or method described in U.S. Publication No.2014/0046303, previously incorporated by reference herein. In one ofthese embodiments, such a device has an internal hollow probe and/orindicator to allow for immediate release of tension if present asdescribed in that application. In other embodiments, the device ismodified to have a non-hollow probe and/or no tension indicator.

In some embodiments, the percutaneous access pathway is established viathe use of a probe and needle mechanism that automatically stops theadvance of the device upon insertion into a body cavity or space (e.g.pleural space), such as also described in U.S. Publication No.2014/0046303. This minimizes user error and allows for the device to beused on differently sized patients (e.g. with different sized chestwalls). In some embodiments, one device fits all patients. In others,part (e.g. changeable access pathways of various sizes on a reusable orstandard insertion device) or all of the device is differently sized fordifferent subgroups so that the appropriately sized device can be chosenfor different subgroups based on, for example, weight, age, gender,length, pre-determined size categories (e.g. Broselow scale), and/orother indicators. These differently sized components may come togetherin a kit, with means for determining proper sizing. Under differentembodiments, the insertion device is disposable or non-disposable anddifferent catheters and/or ports may fit onto one insertion device orhave their own sized insertion devices.

Under various embodiments, the percutaneous access pathway itself ismade of different materials and methods. Under some embodiments, thepercutaneous access pathway is a space (potential or maintained) throughbody tissue; is a deformable or non-deformable catheter; is expandableand/or deflateable plastic or metal (e.g. stent, mesh, rolled material,reinforced wires); and/or is an expandable and/or deflateable catheterfilled with gas (e.g. air) or fluid (e.g. normal saline). Additionally,under some embodiments the catheter is covered partially or fully withadditional material(s), flexible in some cases, that can provideadditional benefits when in contact with the body tissue. Examplesinclude means to increase and/or decrease the cross-sectional area ofthe catheter; to reduce friction and/or the chances of tissue beingpinched in the underlying catheter or mechanism; to decrease the chancesof infection (e.g. antimicrobial properties); and to have drug-releasingproperties (e.g. anesthetic or other anti-pain medications).

There are several embodiments with different mechanisms for expansionand/or contraction of the percutaneous access pathway, for thoseembodiments that contain such a mechanism. Under some embodiments, thisis accomplished via expansion of the channel itself (e.g. catheter(s)filled with gas or fluid). Under one such embodiment, an inflatablecatheter is strengthened sufficiently to allow it to be inserted in adeflated or partially deflated form, and then expanded to push awaysurrounding tissue (e.g. chest wall) sufficiently to form an internalchannel (e.g. large enough accept a chest tube). Under otherembodiments, the expansion and/or deflation mechanism is fully orpartially separate from the expandable and/or deflate-able catheter.This mechanism can be any that changes the diameter of the area of thedevice inserted into the body. Under various embodiments, this mechanismis a balloon (e.g. filled with gas and/or liquid); levers or wires orrods that move to change their cross sectional area; mesh that collapseslengthwise to increase its diameter; screw or other rotational device(s)that change diameter of an overlying portion by varying its length; acollapsed catheter that expands after use of a releasing mechanism; orother mechanisms well known in the art for changing the diameter aroundan inserted structure. Such mechanisms can lie fully or partiallyunderneath, around, or adjacent to the catheter, so that the catheterforms a channel in at least one stage. In different embodiments, suchmechanisms for expansion and/or deflation of the channel are powered bysuction, compressed gas (e.g. air, oxygen), electrical (e.g. outlet,battery), other potential energy (e.g. coiled spring, elastic band),and/or by hand (e.g. twisting a cap, pulling a trigger, compressing asyringe).

In many embodiments, the access pathway is made of a catheter and accesspathway port. In some embodiments, the access pathway port allowsentrance to the catheter to be reversibly or irreversibly sealed, thuspreventing air and/or infection from entering the body cavity. In someembodiments, the connection of an attachment device to the accesspathway port causes the access pathway port to open, thus allowing partor all of the attachment device (e.g. chest tube, surgical equipment,endoscopy camera, video-assisted thoracoscopic surgery device) to enterthe body through the catheter, but not allowing air or infectiousmaterial to enter when an attachment device is not attached. In someembodiments the access pathway port and/or catheter has one or morecheck valves, which allow air to release from the body but not to enterthe body. Under some embodiments, the access pathway port connectionuses a quick connect type mechanism, to expedite attachment and simplifythe procedure.

In many embodiments, the access pathway anchors, stabilizes, and/orsecures the percutaneous access pathway to the body. Examples includestabilization through sutures, staples, glue, and/or tape; tension froman expanded catheter within the body wall; adhesive that holds thecatheter, port, and/or larger disk onto the skin; and/or expansion ofone or more balloon(s) within the body cavity, within the percutaneousaccess pathway, and/or externally. In various embodiments, the catheterand/or port is anchored so as to make the percutaneous access pathwayperpendicular to the skin, at an angle (e.g. to facilitate internalchest tube placement or surgical access), and/or adjustable so as toallow movement to a desired angle.

Many of the embodiments of the present invention contain attachmentdevice(s) for entrance into the percutaneous access pathway. In some ofthese embodiments, the attachment device includes a port that connectsto the body, catheter, and/or access pathway port, so as to allow partor all of the attachment device to enter the body. In some embodiments,after attachment the attachment device has a port which can bereversibly or irreversibly opened, thus allowing part or all of theattachment device (e.g. chest tube, surgical equipment, endoscopycamera, video-assisted thoracoscopic surgery device) to enter the body,but not allowing air or infectious material to contaminate the sterileportion of the attachment device when not attached. In some embodiments,the opening of the attachment device port is caused manually by theoperator (e.g. a button, lever, or switch) and in others is causedautomatically by the attachment of the catheter and/or access pathwayport to the attachment device and/or attachment device port.

In many embodiments, the attachment device contains an external sheath,so as to protect part or all of the internal components from theexternal (e.g. non-sterile) environment and to maintain sterilitywithin. In some of these embodiments, the sheath is formed of flexibletubing (e.g. plastic), collapsible or foldable material, and/or bag orbag-like material. In some of these embodiments, the attachment device(e.g. chest tube, surgical equipment, endoscopy camera, video-assistedthoracoscopic surgery device) can be inserted, manipulated, and/orremoved by the operator while the external sheath maintains sterilitywithin at least that portion of the device that will enter the body. Theattachment device can additionally be hooked up to any external hookupsthat are standard for that device type. For example, under oneembodiment, the attachment device is a chest tube covered by a sheathwith a distal device port. The proximal device end connects to standardchest tube drainage or suction system(s), well known in the art.

In one embodiment, the attachment device is contained fully or partiallywithin a sheath, which connects to the percutaneous access pathway in amanner so as to maintain sterility within the sheath and thus around theattachment device even in a non-sterile operating environment. Theattachment device can be transported so that the external portion of itmay be contaminated, while maintaining sterility within. When about toconnect to the percutaneous access pathway, the distal attachment deviceport is opened (or in another embodiment a distal attachment device capis removed), thus allowing, after connection, the sterile portion of theattachment device within to extend into the body. The attachment devicemay be manipulated by a non-sterile operator via the external protectivesheath.

In some embodiments, the invention is inexpensively manufactured withall or part of it designed to be disposed of after one use. The needlecan be made of metal, such as stainless steel. Other parts may be madeof metal or plastic or other suitable material. Under variousembodiments, different parts are composed of a radio-opaque materialand/or contain radio-opaque markers.

In another embodiment, the inventive device and method includes a meansfor transiently measuring and/or viewing negative pressure.

In another embodiment, the inventive device includes a means forprotecting the user from a needle stick injury when removing theinsertion device from the patient. Under this embodiment, such means canbe arranged from any one of the many self-blunting needle mechanisms forintravenous catheters, phlebotomy, and/or Veress needles that are wellknown in the art. In one embodiment, this mechanism involves theautomatic locking of the probe in its distally extended “blunt”configuration when the insertion device is removed from the percutaneousaccess pathway.

There have been illustrated and described herein methods and devices forforming and/or maintaining a percutaneous access pathway. Whileparticular embodiments of the invention have been described, it is notintended that the invention be limited thereto, as it is intended thatthe invention be as broad in scope as the art will allow and that thespecification be read likewise.

From the foregoing, it can be seen that the present invention providesan effective means for forming and/or maintaining a percutaneous accesspathway within animals, especially humans. This percutaneous accesspathway can be in the chest, abdomen, retroperitoneal, cranium, trachea,abscess, or other potential or real body cavities. Although the exampleof the chest with a thoracostomy procedure placing a chest tube has attimes been used to illustrate the invention, this could also similarlybe, for example, the abdominal cavity with a laparoscopy procedureplacing an abdominal drain (which could give the benefit of repeatlaparoscopy procedures without having to place new ports and/or some ofthese procedures being performed outside of a standard sterile operatingroom). This can also similarly be used with any other surgicalprocedures where a reusable port for repeat procedures and/ormanipulation in a non-sterile environment would be of benefit.

Moreover, it should also be apparent that the device can be made invarying lengths and sizes to treat adults, children, and infants. Whilethe invention has been described with a certain degree of particularity,it is manifest that many changes may be made in the details ofconstruction and the arrangement of components without departing fromthe spirit and scope of this disclosure. It is understood that theinvention is not limited to the embodiments set forth herein forpurposes of exemplification, and that elements of certain embodimentscan be combined with elements of other embodiments. Additional objects,advantages, and novel features of the invention will be set forth in thedescription which follows, and will become apparent to those skilled inthe art upon examination of the following detailed description andfigures. It should be understood that not all of the features describedneed be incorporated into a given method or device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram of a method according to an embodiment of theinvention for forming and/or maintaining a percutaneous access pathway.

FIG. 2 is a side view of a percutaneous access pathway and insertiondevice in accordance with an embodiment of the invention, as assembledprior to use.

FIG. 3 is a side view of a sheathed chest tube with attaching port inaccordance with an embodiment of the invention, as assembled prior touse.

FIG. 4 is a cut-away side view of a percutaneous access pathway andinsertion device in accordance with an embodiment of the invention, asassembled prior to use.

FIG. 5 is a cut-away side view of a sheathed percutaneous tube withattaching port in accordance with an embodiment of the presentinvention, as assembled prior to use.

FIG. 6 is a cross-sectional side view of a percutaneous access pathwayand insertion device in accordance with an embodiment of the presentinvention, as assembled prior to use.

FIG. 7 is a cross-sectional side view of the device of FIG. 6, shownupon contact with the skin.

FIG. 8 is a cross-sectional side view of the device of FIG. 6, shownupon penetration of the chest wall.

FIG. 9 is a cross-sectional side view of the device of FIG. 6, shownupon entrance into the pleural space.

FIG. 10 is a cross-sectional side view of the device of FIG. 6, shownupon expanding transcutaneous entrance into the pleural space.

FIG. 11 is a cross-sectional side view of the device of FIG. 6, shownafter removal of the insertion device.

FIG. 12 is a cross-sectional side view of the devices of FIGS. 3 and 6,shown after locking on the sheathed chest tube mechanism.

FIG. 13 is a cross-sectional side view of the devices of FIGS. 3 and 6,shown after partial insertion of the slide-able internal chest tube.

FIG. 14 is a cross-sectional side view of the devices of FIGS. 3 and 6,shown after removal of the chest tube sheath device and with theinternal dilating catheter mechanism released.

FIG. 15 is a side view of percutaneous access pathway and attachmentdevices in accordance with an embodiment of the invention, shown whenattached to each other.

FIG. 16 is a cut-away side view of percutaneous access pathway andattachment devices in accordance with an embodiment of the invention,shown when attached to each other.

DETAILED DESCRIPTION OF THE INVENTION

Referring to the drawings, FIG. 1 generally shows a method and workflow300 according to an embodiment of the invention for forming and/ormaintaining a percutaneous access pathway. This method and workflow 300should be assumed to fit within standard emergency, pulmonary, andsurgery protocols well known in the art (and not described here).Additionally, methods of standard needle use and safety, patientcleaning and sterilization, equipment disposal, suction setup and otherstandard medical practice well known in the art are not described here.The method 300 starts with providing a percutaneous access pathway atstep 301. Under numerous embodiments, said access pathway includes aport and a catheter (i.e. an elongated tubular member). Under many butnot all embodiments, said percutaneous access pathway also comes with aninsertion device that includes a dilatational member. Under severalembodiments, the dilatational member is initially positioned at leastpartially within the catheter and sized to dilate a portion of the bodywall (e.g. chest wall) when activated.

Next, the percutaneous access pathway is inserted percutaneously intothe body at step 302 (e.g. into the pleural space). Under some but notall embodiments, the device has an auto-stopping mechanism to stop theadvance of the device into the body at the appropriate depth. Underseveral embodiments, the dilatational member then dilates to expand aportion of the body wall (e.g. chest wall). Under several embodiments,the access pathway has a port that can be reversibly connected toadditional devices. Under most of these embodiments, the port remainsclosed by default (unless attached to another device). If a percutaneousaccess pathway had already been formed (e.g. during thoracic surgery,after standard incision of the chest wall or use of the Seldinger orother previously noted chest tube insertion techniques, after removal ofa prior standard chest tube) then the access pathway could simply beinserted without need for an expandable catheter, insertion device,and/or dilatational mechanism. Additionally, under at least oneembodiment, the percutaneous access pathway is a potential space createdby the surgeon.

Next, after removal of the dilatational mechanism (in those embodimentsin which it is present) the access pathway is connected by the user toan attachment device at step 304, which can then be inserted into thebody. Under several embodiments, the attachment device has its own port.In some of these embodiments, the attachment device port connects to aport on the access pathway. In others, it connects directly to the skinvia adhesive or other well-known means. Under numerous embodiments, theattachment device is contained fully or at least partially within asterile sheath.

Next, the port of the percutaneous access pathway is opened at step 306,so as to provide access into the body (i.e. through the chest wall andinto the pleural space). Under some embodiments, this happensconcurrently with step 304 and under others happens sequentially. Undernumerous embodiments, this occurs by opening a port on the accesspathway and inserting the attachment device. Under several embodiments,the attachment device has a cap, which is removed before connecting itto the access pathway, and/or its own port, which opens after beingconnected to the access pathway port. Under several embodiments,connection of the attachment device to the access pathway allowsinsertion of part of the attachment device into the patient (e.g. chesttube through the access pathway and into the pleural space) via aninternal sterile space, regardless of the sterility of the outerenvironment. Under some embodiments, this connection uses a quickconnect type mechanism to expedite attachment and simplify theprocedure. In various embodiments, the access pathway port opens onlywhen attached to the attachment device. Likewise, under variousembodiments, the attachment device port (if present) is opened manuallyvia the removal of a cap and/or only when attached to the access pathwayport.

Next, the attachment device is inserted into the body at step 310 (e.g.a chest tube inserted into the plural space). Under several embodimentsthe attachment device is contained fully or at least partially within asterile sheath that can be manipulated by the user to insert the deviceinto the body. Some embodiments include a means to secure the insertedportion of the attachment device at its desired depth into the bodywithout compromising the sterility of the inserted device. Someembodiments include additional methods to secure the device to thepatient, at steps 302, 304, and/or 310. Many embodiments include methodsfor the device to be later removed, which under some embodiments includethe contraction of the access pathway.

Moving now to FIGS. 2, 3, 4, and 5, one embodiment of the presentinvention is illustrated and generally indicated as 10. For ease ofreference, distal shall refer to the end of the device farthest awayfrom the user, while proximal shall refer to the end of the deviceclosest to the user.

This embodiment generally comprises an assembly 10 made up of at leastone of three type of components: access pathway 20, insertion device 60,and attachment device 140. Access pathway 20 includes catheter 30 andaccess pathway port 40. Insertion device 60 includes access holder 70,insertion body 80, rotational cap 90, probe 100, needle 110, andexpansion mechanism 120. Attachment device 140 includes device port 150,chest tube 170, sheath 180, and chest tube cap 190.

Moving now additionally to FIG. 6, access pathway 20 sits within accessholder 70 of insertion device 60 so that it can be removed frominsertion device 60 distally but not proximally. Further, access pathway20 includes catheter 30 sitting within access pathway port 40. Catheter30 encloses expansion mechanism 120 in this embodiment holding tight tothe opening mechanism due to the elastic nature of catheter 30. Withincatheter 30 are rigid rods 32, which keep the internal passage of thecatheter from narrowing at one end in comparison to the other. Accesspathway port 40 contains access pathway channel 42 connecting tocatheter locking area 44 and catheter release mechanism 50. As insertionprong 86 of insertion device 60 is within access pathway channel 42 andaccess pathway entrance 46, this causes access pathway port door 48 toremain open despite the tension placed on it to close by torsion spring49.

Rotational cap 90 of insertion device 60 attaches onto insertion body 80so as to allow rotational movement. Needle 110, probe 100, and expansionmechanism 120 pass into access pathway 20 and attach directly toinsertion body 80. Expansion prong 122 of expansion mechanism 120 isinserted proximally onto insertion prong 86 of insertion body 80, whileprobe 100 is within needle 110 of hollow screw mechanism 130 ofexpansion mechanism 120, and all extend more proximally out the proximalportion of insertion prong 86. Rotational cap gear 91 of rotation cap 90interlocks with dumbbell gear 96 so as to transfer rotational force fromcap 90 to hollow screw mechanism 130 within locking block 94. Spring 92biases probe holder 84, which is connected to probe 100, so that probe100 extends distally to the end of needle 110 in its initial position.Further, in this initial position, probe holder 84 moves distally tocause prong 82 to engage with grooves 72 on access holder 70.

Moving now specifically to FIG. 3 and FIG. 5, attachment device 140 isshown, having device port 150 at its distal end and chest tube cap 190at its proximal end. The middle of attachment device 140 contains chesttube 170 within sheath 180. Device port 150 contains device door 152biased to close behind device entrance 154 by a torsion spring (notshown). It also contains locking prong 156 and chest tube clamp 160.Chest tube 170 is connected to chest tube cap 190, but slides withindevice port 150 such that it can extend out of device entrance 154 ifsheath 180 is collapsed distally by the operator. Further, the areawithin sheath 180 is sterile such that the chest tube within will alsoremain sterile despite outside manipulation due to closed door 152 andchest tube cap 190, the exit 192 of which is also in various embodimentscovered with a removable cap or has an automatic door similar to deviceport 150. Exit 192 can be connected to suction or other standard chesttube drainage means.

Moving now additionally to FIGS. 6-14, assembly 10 of an embodiment ofthe invention is described in use. In FIG. 6 the assembly 10 is shownbefore insertion. The tip 102 of probe 100 extends out distally from thetip 112 of needle 110, due to the biasing action from spring 92 on probeholder 84 and thus probe 100 as previously described. As probe holder 84is in its distal position, it causes prong 82 to engage with grooves 72on access holder 70. Thus, access pathway 20 and access holder 70 areunable to move in relation to insertion body 80.

FIG. 7 demonstrates when probe end 102 first touches the skin 200 of theexample of a human body, with skin 200 covering a chest wall 204 withinwhich lies a pleural cavity 206 and lung 208. This causes probe tip 102to move proximally in reference to needle tip 112, and likewise probe100 to move proximally in reference to needle 110. As probe 100 isadhered to probe holder 84 and needle 110 is adhered to locking block 94(which is further adhered to insertion body 80), this causes holder 84to start to move proximally in relation to insertion body 80 androtational cap 90, thus compressing spring 92. As probe holder 84 is inits proximal position, it releases prong 82 from engagement with grooves72 on access holder 70. Thus, access pathway port 40 and catheter 30(i.e. access pathway 20) and access holder 70 are now able to move inrelation to insertion body 80. Probe tip 104 can be viewed by theoperator as in its proximal position through viewer chamber 93.

Moving now to FIG. 8, when needle 110 pierces skin 200 and starts toenter chest wall 204, it causes probe tip 102 to stay proximal inreference to needle tip 112 (thus, continuing to release prong 82 fromengagement with grooves 72). Once the distal portion of access holder 70and the distal portion of access pathway port 40 touch skin 200, furtherdistal movement of the insertion device 60 causes it to move distally inrelation to access pathway port 40 and access holder 70, thus causingcatheter 30 (along with probe 100, needle 110, and expansion mechanism120) to move further into the body, pushed distally by insertion prong86 (and insertion device 60).

Moving now to FIG. 9, once needle tip 112 pierces chest wall 204 andenters pleural space 206, spring 92 acting upon probe holder 84 forcesprobe 100 to move distally in relation to insertion body 80 and needle110, thus projecting probe tip 102 distal to needle tip 112 (and servingto protect lung 208 and other vital organs from the sharp distal needletip 112). Additionally, as probe holder 84 is in its distal position itcauses prong 82 to engage with grooves 72 on access holder 70, thusinhibiting any further distal movement of insertion body 80 and stoppingthe distal advance into the body of insertion prong 86 and catheter 30(along with probe 100, needle 110, and expansion mechanism 120).

Moving now to FIG. 10, once penetrated into pleural space 206, catheter30 is then expanded to a larger cross-sectional diameter. To do so,rotational cap 90 is rotated in relation to insertion body 80, whichengages rotational cap gear 91 to cause dumbbell gear 96 (shown in FIG.4) to rotate. Dumbbell gear 96 then transfers the rotational force tohollow screw mechanism 132 within locking block 94, which causes thedistal tip of expansion prong 122 to collapse proximally, thusadditionally expand it circumferentially to dilate catheter 30 and chestwall 204. Finally, once catheter 30 reaches a pre-set dilation size,catheter lock 52, which is biased distally by spring 54, moves distallyinside catheter 30, thus locking catheter 30 in its expandedconfiguration. When so locked, catheter ridge 32 fits into catheterlocking area 44 so as to inhibit proximal or distal movement of catheter30 in relation to access pathway port 40.

Moving now to FIG. 11, the assembly after removal of insertion device 60(not depicted) is shown, with access pathway port 40 and catheter 30(i.e. access pathway 20) secured onto the body using any of theaforementioned techniques. Catheter 30 remains in its expandedconfiguration due to catheter lock 52 (held distally by spring 54) andcannot move proximally or distally in relation to access pathway port 40due to catheter locking area 44 around catheter ridge 32. With theremoval of insertion device 60, there is a free pathway from pleuralspace 206 through chest wall 204 via the inside chamber 36 of catheter30 and the access pathway 42 of access pathway port 40. This pathway isonly obstructed to the external environment by access pathway port door48, which has automatically closed after removal of insertion prong 84(shown in FIG. 10) due to the biasing of torsion spring 49 (shown inFIG. 4). Thus, no air or infection may enter the body through accesspathway 20. At this or a prior or later stage, access pathway port 40and catheter 30 (i.e. access pathway 20) may additionally then besecured to the patient by one of the many common means of adheringdevices to patient skin known in the art (e.g. tape, glue, suture,staples, etc.).

Moving now to FIG. 12, the assembly upon reversible connection ofattachment device 140 to port 40 is shown. Access pathway port 40 anddevice port 150 both have similar mechanisms that allow the two tosecurely connect via their respective locking keys (47 and 156, shown inFIGS. 4 and 5) and that upon rotation in relation to each other forcethe opposite port door to open (48, shown in FIG. 4, and 152). Thismechanism only allows the port doors to open when an opposing port isattached and prohibits removal of the connected port until the doors canclose fully, which provides the benefit of ensuring an internallysterile space. If placed after the exterior of access pathway port 40has become unsterile, the proximal portion of access pathway port 40should be cleaned with a sterilizing agent, just prior to connection todevice port 150. Device port 150 can be similarly cleaned prior to useor may have an additional cap distally, which is removed just prior touse to maintain sterility beneath it and on the distal surface of deviceport 150. Access pathway port 40 also contains O-ring 43, which assistsin ensuring an airtight seal between the two connecting ports. Once bothports are connected, there is an uninterrupted transcutaneous accesspathway from pleural space 206 through the inside catheter chamber 36,and the access pathway port access pathway 42, catheter door 46, anddevice port door 154 to chest tube 170.

FIG. 13 shows the assembly upon insertion of chest tube 170 throughaccess pathway port 40 and catheter 30 (i.e. access pathway 20). Asthere is an uninterrupted transcutaneous access pathway within port 40,catheter 30, and device port 150, chest tube 170 can be manipulated bythe operator within collapsible sheath 180 to slide it distally throughcatheter 30 (within chest wall 204) and into pleural space 206. Clamp160 of device port 150 can then be engaged to hold chest tube 170 at thedesired length within the body. Since chest tube 170 is in place, portdoors 48 and 152 (described previously) cannot close, and thus the portsremain locked onto each until removal of chest tube 170.

FIG. 14 shows the assembly in the middle of removal, after thedisengagement of attachment device 140 (no longer shown). Catheterrelease 56 is pulled proximally, overcoming spring 54 and thus movingcatheter lock 52 proximally. This releases catheter 30 to collapse andreduce its cross-sectional diameter, thus making it easier to remove itfrom chest wall 204. Catheter 30 can then be pulled out proximally bypulling on access pathway port 40.

Moving now to FIGS. 15 and 16, an example of another embodiment ofdevice 10 of the present invention device is illustrated. FIG. 15 showsaccess pathway 20, consisting of catheter 30 and access pathway port 40,reversibly connected to attachment device, consisting of device port150, chest tube (not shown), and sheath 180. Access pathway 20, in thisembodiment, is inserted into the body to sit flush with the skin (notshown) and does not vary the length of catheter 30 extending out ofaccess pathway port 40 as in the previous embodiment, thus reducingparts and complexity. Device port 150 connects via a quick-lock fashionwith access pathway port 40 to reversibly connect the two components.

FIG. 16 shows the internal workings of this embodiment. In thisembodiment, access pathway port 40 and device port 150 attach to eachother via an integrated locking mechanism 156, which upon rotation ofattachment device 140 reversibly locks it to access pathway port 40while causing the port door 48 to open. This mechanism allows port door48 to open only when device port 150 is attached, which provides thebenefit of ensuring an internally sterile space. In this embodiment,there is no door on attachment device 140, but rather a cap that keepsthe distal end of device port 150 sterile until it is removed prior touse (not shown). Access pathway port 40 also contains areas for O-rings43, to ensuring an airtight seal between the two connecting ports (andalso internally within access pathway port 40).

Additionally, FIG. 16 shows that, under this embodiment, the rotation ofaccess pathway port 40 and device port 150 in relation to each othercauses a screw mechanism to move door holder 41 linearly within port 40,thus opening or closing door 48, with door 48 biased to the closedposition by a spring (not shown). When chest tube 170 is insertedthrough port 40, door 48 is unable to close and thus attachment device140 is unable to be removed from access pathway 20 until chest tube 170is pulled out.

There have been illustrated and described herein methods and devices forforming and/or maintaining a percutaneous access pathway. Whileparticular embodiments of the invention have been described, it is notintended that the invention be limited thereto, as it is intended thatthe invention be as broad in scope as the art will allow and that thespecification be read likewise.

Furthermore, it will be appreciated by those skilled in the art that thedevice can be used on other types of potential spaces and body cavities.Examples include the abdominal cavity, trachea, skull and other bones,vessels, bladder and other hollow organs, as well as abscesses and othercollections of fluid (e.g. empyema, ascites, and pleural and othereffusions).

For example, it will be appreciated by those skilled in the art that theaccess pathway of the current invention may function as a standardcatheter, Penrose drain, pigtail catheter, chest tube, tracheostomytube, endotracheal tube, venous or arterial catheter, thoracentesistube, paracentesis tube, abscess drainage or other medical tube orcatheter for placement into a body cavity. Furthermore, it will beappreciated by those skilled in the art that the current invention maybe used for placing access pathways into the abdominal cavity,abscess(es), the thoracic cavity, the cranium, bone, the trachea, veins,arteries, and other organs and/or potential spaces.

Furthermore, while parts of embodiments of the invention were describedas having certain shapes, and being made of certain materials, it willbe appreciated that other materials and shapes can be utilized. It willtherefore be appreciated by those skilled in the art that yet othermodifications could be made to the provided invention without deviatingfrom its spirit and scope as so claimed.

The invention claimed is:
 1. A device for forming and/or maintaining apercutaneous access pathway into a body of a patient, comprising: anaccess pathway catheter configured to connect an internal portion of abody of a patient to an external environment; an access pathway portconfigured to maintain a barrier between the internal portion of thebody and the external environment when in a closed position, the accesspathway port including a distal opening through which the access pathwaycatheter is configured to extend into the internal portion of the body;an attachment device connectable to the access pathway port andconfigured to selectively cause the access pathway port to open byopening one or more doors in the access pathway; an internally sterileattachment device sheath at least partially surrounding the attachmentdevice and configured to enable insertion of at least part of theattachment device into the internal portion of the body through the oneor more doors in the access pathway when the attachment device isconnected to the access pathway port; and an insertion device configuredto cause the access pathway catheter to be inserted into the internalportion of the body of the patient, wherein the insertion device isconfigured to selectively cause the access pathway catheter to expand.2. The percutaneous access pathway of claim 1, wherein the one or moredoors in the access pathway includes a door in the access pathway portthat is configured to be reversibly opened and closed.
 3. Thepercutaneous access pathway of claim 1, wherein the attachment device isconfigured to be reversibly connected to and disconnected from theaccess pathway port.
 4. The percutaneous access pathway of claim 1,wherein the attachment device is configured to be manipulated from theexternal environment through the attachment device sheath whilemaintaining a barrier from the external environment to within the bodywith the access pathway port and the attachment device sheath.
 5. Thepercutaneous access pathway of claim 1, wherein the internal portion ofthe patient's body is the chest cavity.
 6. The percutaneous accesspathway of claim 1, wherein the access pathway catheter and accesspathway port are unitarily formed as a single component.
 7. Thepercutaneous access pathway of claim 1, wherein the access pathway isconfigured to be used for a tube thoracostomy.
 8. The percutaneousaccess pathway of claim 1, wherein the internal portion of the patient'sbody is inside the abdominal cavity, trachea, skull, bone, vessel,bladder, a hollow organ, abscess, and/or a collection of fluid in thebody.
 9. The percutaneous access pathway of claim 1, wherein the accesspathway functions as a standard catheter, Penrose drain, pigtailcatheter, chest tube, tracheostomy tube, endotracheal tube, venous orarterial catheter, thoracentesis tube, paracentesis tube, abscessdrainage or other medical tube, and/or a catheter for placement into abody cavity.
 10. The percutaneous access pathway of claim 1, wherein theaccess pathway is used for placing an access pathway into an abdominalcavity, abscess, thoracic cavity, cranium, bone, trachea, vein, and/orartery.
 11. The percutaneous access pathway of claim 2, wherein theaccess pathway is configured to enable opening of the door in the accesspathway port when the attachment device is connected to the accesspathway port.
 12. The percutaneous access pathway of claim 2, whereinthe access pathway is configured to inhibit removal of the attachmentdevice from the access pathway port while the door in the access pathwayport is open.
 13. The percutaneous access pathway of claim 1, whereinthe attachment device is configured to connect to suction in theexternal environment.
 14. The percutaneous access pathway of claim 1,wherein the attachment device sheath is air-impermeable.
 15. Thepercutaneous access pathway of claim 1, wherein the access pathway portand/or access pathway catheter contain an adhesive configured to securethe access pathway to the body of a patient.